EP3740264A1 - Mécanisme d'administration de médicament - Google Patents

Mécanisme d'administration de médicament

Info

Publication number
EP3740264A1
EP3740264A1 EP19703535.5A EP19703535A EP3740264A1 EP 3740264 A1 EP3740264 A1 EP 3740264A1 EP 19703535 A EP19703535 A EP 19703535A EP 3740264 A1 EP3740264 A1 EP 3740264A1
Authority
EP
European Patent Office
Prior art keywords
plunger rod
flexible
flexible plunger
assembly
drug delivery
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP19703535.5A
Other languages
German (de)
English (en)
Inventor
Sudeshna DUTTA RAY
Scott R. Gibson
Daniel Eduardo Groszmann
Mehran Mojarrad
Robert Allen DEES
Jonathan Dean JOHNSON
Antonio S. MURCIA
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Amgen Inc
Original Assignee
Amgen Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Amgen Inc filed Critical Amgen Inc
Publication of EP3740264A1 publication Critical patent/EP3740264A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033—Spring-loaded one-shot injectors with or without automatic needle insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
    • A61M5/31583—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
    • A61M5/31583—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod
    • A61M5/31586—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod performed by rotationally moving or pivoted actuator, e.g. an injection lever or handle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A61M2005/31518—Piston or piston-rod constructions, e.g. connection of piston with piston-rod designed to reduce the overall size of an injection device, e.g. using flexible or pivotally connected chain-like rod members

Definitions

  • the present disclosure generally relates to drug delivery devices and, more particularly, to delivery mechanisms for drug delivery devices.
  • Some drug delivery devices include a reservoir for containing a drug and a delivery system that pushes the drug out of the reservoir using a plunger and a plunger rod.
  • Conventional plunger rods can be rigid such that the rod projects rearwardly from the reservoir prior to an injection operation. This configuration can impact a size and footprint for the drug delivery device.
  • the drive mechanism for moving rigid plunger rods can be complicated and costly to manufacture.
  • the present disclosure sets forth flexible plunger rods, as well as delivery mechanisms and drug delivery devices incorporating the flexible plunger rods, embodying advantageous improvements to lower manufacturing and material costs.
  • a delivery assembly for a drug delivery device includes a reservoir having a tubular housing that extends along a longitudinal axis and has a delivery opening at a distal end.
  • the delivery assembly further includes a plunger disposed within the reservoir in engagement with the housing and a flexible plunger rod operably coupled to the plunger.
  • a feeding mechanism of the delivery assembly is coupled to the flexible plunger rod and configured to drive the flexible plunger rod along the longitudinal axis of the housing to drive the plunger towards the distal end.
  • the delivery assembly can include a plunger rod housing that has a curved interior extending therethrough to bend the flexible plunger rod in a storage configuration.
  • the curved interior has a first opening disposed adjacent to the reservoir and a second, opposite opening disposed at an angle with respect to the first opening.
  • the flexible plunger rod can be a spring having a predetermined preload amount.
  • a coil member of the spring can have a circular cross section.
  • a coil member of the spring can have a rectangular cross-section.
  • the feeding mechanism can include a drive gear having a central opening for the spring to extend therethrough.
  • the central opening has a thread that is configured to engage a spring of the flexible plunger rod such that rotation of the drive gear relative to the spring causes the spring to move longitudinally through the drive gear.
  • the feeding mechanism can further include a motor that has a driveshaft operably coupled to the drive gear and the delivery assembly can further include a controller that is configured to maintain a generally constant injection speed by controlling the operation of the motor.
  • the thread can include a shim that extends between adjacent coils of the spring or a threaded cavity that is configured to engage coils of the spring.
  • the delivery assembly can further include a stabilizer member extending within the flexible plunger rod and coupled thereto, the stabilizer member having an elongate body with a flat configuration to control flexing of the flexible plunger rod.
  • the delivery assembly can further include a coupling member that is mounted to an end of the flexible plunger rod.
  • the coupling member and plunger have cooperating structures that are configured to engage one another and prevent rotation of the flexible plunger rod relative to the plunger.
  • a drug delivery device such as an on-body drug delivery device or an autoinjector drug delivery device, is described herein that includes a delivery assembly of the above embodiments.
  • a method for dispensing a drug is described herein that includes driving a flexible plunger rod through an internal opening of a drive gear with a radially extending thread engaging the flexible plunger rod and driving a plunger longitudinally within a reservoir containing a drug with the flexible plunger rod.
  • driving the flexible plunger rod through the internal opening of the drive gear can include driving the flexible plunger rod through the internal opening of the drive gear with a shim extending through adjacent coils of the flexible plunger rod or with a thread cavity engaging coils of the flexible plunger rod.
  • the method can further include coupling the flexible plunger rod and the plunger with a coupling member, where the coupling member and plunger have cooperating structures such that, with the coupling member mounted to a distal end of the flexible plunger rod, the flexible plunger rod and plunger are restricted from rotating with respect to one another.
  • the method can further include storing the flexible plunger in a bent configuration.
  • the method can further include preloading the flexible plunger rod a predetermined amount.
  • the method can further include controlling operation of a motor having a driveshaft operably coupled to the drive gear to maintain generally constant rotation of the drive gear and thereby generally constant movement of the plunger and flexible plunger rod through the reservoir.
  • FIG. 1 is a perspective view of a delivery mechanism for a drug delivery device showing a first embodiment of a flexible plunger rod in accordance with various embodiments of the present disclosure
  • FIG. 2 is a perspective view of a delivery mechanism for a drug delivery device showing a second embodiment of a flexible plunger rod in accordance with various embodiments of the present disclosure
  • FIG. 3 is a cross-sectional view of a drive gear for the delivery mechanism of Fig. 1 or Fig. 2;
  • FIG. 4 is a perspective view of a delivery mechanism for a drug delivery device showing a stabilizer for a flexible plunger rod in accordance with various embodiments of the present disclosure
  • Fig. 5 is a top plan view of the delivery mechanism for a drug delivery device of Fig. 4;
  • FIG. 6 is a perspective view of a flexible plunger rod and drive nut in accordance with various embodiments of the present disclosure
  • Fig. 7 is a cross-sectional view of the flexible plunger rod and drive nut of Fig. 6 mounted within a drive housing;
  • FIG. 8 is a side cross-sectional view of an on-body injector drug delivery device showing a delivery mechanism and a cartridge piercing assembly in accordance with various embodiments of the present disclosure
  • Fig. 9 is a top plan view of internal components of an on-body drug delivery device in accordance with various embodiments of the present disclosure.
  • Fig. 10 is a side cross-sectional diagrammatic view of an on-body drug delivery device in accordance with various embodiments of the present disclosure.
  • FIG. 11 is a side cross-sectional view of an autoinjector drug delivery device showing a flexible plunger rod in accordance with various embodiments of the present disclosure.
  • a flexible plunger rod, drug delivery mechanism, drug delivery device, and methods are described herein that utilize a flexible configuration to thereby lower manufacturing costs and decrease device size while providing exemplary drug delivery operations. More specifically, rather than a rigid plunger rod as utilized in conventional drug delivery devices, the embodiments described herein include a flexible plunger rod that can be stored in curved configuration to thereby reduce a footprint of the device. Additionally, a drive mechanism for such a flexible plunger rod can be simplified and less costly as compared to conventional mechanisms.
  • the present disclosure relates to drug delivery devices in general and provides two exemplary embodiments including an on-body injector and an autoinjector.
  • the technology described herein, however, can also be incorporated into other suitable drug delivery devices.
  • a drug delivery assembly 10 is shown in Fig. 1 that includes a reservoir or cartridge 12 having a tubular housing 14 configured to store or contain a drug therein.
  • the reservoir 12 includes a delivery opening 18 at a distal end 20 to deliver the drug to a cannula or other delivery structure (Fig. 10) and an open proximal end 22.
  • a plunger 24 is disposed within the reservoir 12 adjacent to the proximal end 22 and engaged by a flexible plunger rod 26.
  • the flexible plunger rod 26 is a spring that includes a coiled member 28.
  • the coiled member 28 can have a generally circular cross-section as shown in Fig. 1 , a rectangular cross-section as shown in Fig. 2, or other suitable shapes.
  • the spring of the plunger rod 26 can be an extension spring that is in a preloaded state such that the individual coils of the coiled member 28 are fully collapsed on one another without external forces acting on the spring and pulling the coils apart from one another requires a larger force than the preloaded amount.
  • the preloaded amount can be adjusted to tailor the buckling characteristics of the spring so that the spring does not buckle during a drug delivery operation.
  • the preload amount can be in a range of about 0.5 pounds to about 3 pounds and, more preferably, in a range of about 0.75 pound to about 2 pounds, and more preferably, about 1 pound.
  • utilizing a coiled member 28 cross-sectional shape having flat sides, such as the rectangular configuration shown in Fig. 2 can aid in preventing undesirable buckling due to the adjacent surfaces abutting one another over a greater surface area than curved surfaces.
  • a drive mechanism 30 including a gear train 32 and a motor 36 having a drive shaft 38 coupled to the gear train 32 such that rotation of the drive shaft 38 causes rotation of the gears in the gear train 32.
  • the gear train 32 can include gears of desired sizes to optimize gear ratios and the associated gear reduction for particular configurations.
  • the gear train 32 includes a drive gear assembly 34 that engages the plunger rod 26 to drive the plunger rod 26 through the reservoir 12.
  • the drive gear assembly 34 includes a drive gear 40 interconnected with the other gears of the gear train 32 and a plunger rod drive member 41 that is coupled to the drive gear 40 via interacting portions 42, such as a rectangular plug and corresponding opening as shown, to rotate along with the drive gear 40.
  • the drive member 41 has a tubular configuration with an interior 44 that is sized so that the plunger rod 26 can extend through the drive member 41.
  • a thread or shim 46 is integrated with or secured to the drive member 41 , such that the shim 46 extends into the interior 44 of the drive member 41 and between adjacent coils in the spring of the plunger rod 26.
  • the delivery assembly 10 can include a stabilizer 27 having an elongate body 29 with a flat configuration, such that the body 29 can be flexed along a plane perpendicular to the width of the body while also resisting being flexed along other planes.
  • the stabilizer 27 is disposed within the flexible plunger rod 26 to control the flexure thereof. With this configuration, the stabilizer 27 allows the plunger rod 26 to have a curved storage position as shown in the figures and prevents the plunger rod 26 from rotating or buckling undesirably during storage and use.
  • the body 29 extends between a proximal end 31 that is disposed adjacent to a proximal end 33 of the plunger rod 26 and a distal end 35 disposed adjacent to the distal end 48 of the plunger rod 26.
  • one or both of the ends 31 , 35 of the stabilizer 27 can be secured, such as by welding, fasteners, adhesive, and the like, to a corresponding end 33, 48 of the plunger rod 26 to ensure that the stabilizer 27 travels with the plunger rod 26 as it is driven during operation.
  • the distal end 35 of the stabilizer 27 can include a foot portion 37 with outwardly and rearwardly projecting portions 39, 43.
  • the outwardly projecting portion 39 extends generally perpendicular to the body 29 to be disposed adjacent to the distal end 48 of the plunger rod 26 and secured thereto.
  • the stabilizer 27 can be formed from any suitable material, such as sheet metal, a polymer, and so forth.
  • a drive member 45 providing an alternative to the drive member 41 and shim 46 described above is shown in Figs. 6 and 7.
  • the drive member 45 includes a central throughbore 47 sized to receive the plunger rod 26 therethrough.
  • An interior surface 49 of the throughbore 47 includes a thread cavity 51 extending therearound configured to engage the coiled member 28 of the plunger rod 26, such that rotation of the drive member 45 causes the thread cavity 51 to drive the plunger rod 26 through the throughbore 47.
  • the delivery assembly 10 can further include a housing 53 having a recess 55 in a distal end 57 thereof sized to receive drive member 45 and an elongate throughbore 59 extending from the recess 55 to a proximal end 61.
  • the elongate throughbore 59 extends along an axis and is sized so that the portion of the plunger rod 26 engaging the thread cavity 51 is not flexed or curved.
  • the drive member 45 can be secured within the recess 55 by any suitable mechanism, including welding, fasteners, friction, and so forth.
  • a distal end 48 of the plunger rod 26 fixedly couples to the plunger 24 so that the plunger rod 26 cannot rotate with respect to the plunger 24.
  • This fixed coupling can have any suitable configuration.
  • the plunger rod distal end 48 can be secured to a coupling member 50 that includes structures 52 that interconnect with corresponding structures 54 on a rear end 56 of the plunger 24.
  • one of the structures 52, 54 can be splines and the other of the structures 52, 54 can be slots, such that, once the structures 52, 54 are interconnected, the disc 50 and plunger 24 cannot rotate with respect to one another.
  • the plunger rod distal end 48 can be embedded within or bonded to the plunger 24. With these configurations, the plunger rod 26 is prevented from rotating during a delivery operation by virtue of the friction between the plunger 24 and the reservoir 12. As such, all movement transferred to the plunger rod 26 by the drive gear assembly 34 is converted to longitudinal movement down the reservoir 12.
  • the drug delivery assembly 10 and a cartridge piercing assembly 58 are disposed or mounted within a housing 62 for an on-body drug delivery device 64.
  • the cartridge piercing assembly 58 includes a piercing needle 66 and a fluid flow path 70 coupled to the piercing needle 66.
  • the distal end 20 of the reservoir 12 tapers to the delivery opening 18 and a septum 72 extends over the delivery opening 18 to seal the reservoir 12 and maintain the sterility of a drug 16 therein.
  • a drive mechanism 68 shifts the reservoir 12 so that the piercing needle 66 is driven through the septum 72 to fluidly couple the flow path 70 with the reservoir 12.
  • the piercing needle 66 can be shifted through the septum 72 to fluidly couple the flow path 70 with the reservoir 12.
  • the drive mechanism 10 can operate to move the plunger 24 down the reservoir 12 to push the drug 16 through the piercing needle 66 and into the flow path 70.
  • the drug delivery device 64 can further include a gear box 78 enclosing or partially enclosing the gear train 32 and a spring housing or portion 80.
  • the device housing 62 can have a smaller footprint than a housing having to enclose a rigid plunger rod that projects rearwardly from the reservoir 12.
  • the spring portion 80 can include a curved pathway or bore 82 that the plunger rod 26 extends along while in a storage state.
  • the pathway 82 includes a curved sidewall 84 and a first end opening 86 adjacent to the reservoir 12. So configured, the spring portion 80 bends the flexible plunger rod 26 to a desired curved configuration within the housing 62 to thereby decrease a required longitudinal length.
  • the pathway 82 can extend along any desired path to bend the plunger rod 26 in desired storage configurations, such as along a 45 degree angle, a 90 degree angle, a 135 degree angle, a 180 degree angle, and so forth.
  • the housing 62 is sized to receive the delivery assembly 10, the cartridge piercing assembly 58, and a needle insertion assembly 76.
  • a diagram of the needle insertion assembly 76 is shown in Fig. 10. Examples of needle insertion assemblies may be found in U.S. Patent Nos. 7, 144,384 and 7, 128,727, which are incorporated by reference herein for all purposes.
  • the needle insertion assembly 76 includes a cannula or needle 88 that is movable between a storage state (not shown) where the cannula 88 occupies a retracted position with a terminal end 90 concealed inside the housing 62 and a delivery state where the cannula 88 occupies an extended position where the terminal end 90 extends out of (e.g., projects from) the housing 62.
  • a storage state not shown
  • the cannula 88 occupies a retracted position with a terminal end 90 concealed inside the housing 62
  • a delivery state where the cannula 88 occupies an extended position where the terminal end 90 extends out of (e.g., projects from) the housing 62.
  • the device 64 also includes a controller 92 that is coupled to the delivery assembly 10, the cartridge piercing assembly 58, and the needle insertion assembly 76 to control operation of each of the assemblies. More specifically, the controller 92 operates the needle insertion assembly 76 to move the cannula 88 so that the terminal end 90 is injected to a desired subcutaneous position, operates the cartridge piercing assembly 58 to pierce the septum 72 to fluidly couple the flow path 70 to the reservoir 12, and operates the delivery assembly 10 to move the flexible plunger rod 26 to thereby drive the plunger 24 through the reservoir 12 and force the drug 16 into the flow path 70 and out of the cannula 88 into the patient P.
  • the controller 92 can further be coupled to a user input or switch device 93, such as a pushbutton, touchscreen, and so forth, and be configured to operate the drug delivery device 64 in response to an actuation of the user input device 93.
  • the controller 92 may include a programmable processor 94 and a memory 96, and be coupled to a power supply 74.
  • the memory 96 can store logic (e.g., programming) that is executable by the processor 94 for operating the drug delivery device 64.
  • the controller 92 can be programmed prior to being disposed within the housing 62. In some embodiments, the controller 92 may not be reprogrammed after installation. In other embodiments, the controller 92 may be able to communicate with a remote device such as a controller, smart phone, etc., for reprogramming even after it is disposed and sealed within the housing 62.
  • the controller 92 can modulate the flow rate of the drug 16 into the patient. Accordingly, the controller 92 can be programmed for desired flow rates and/or be adjustable by a user to a desired flow rate. Additionally, the controller 92 can be programmed for a delayed delivery operation.
  • the drug delivery device 64 can also include a communication module 98 disposed on-board the drug delivery device 64 and in communication with the controller 92.
  • the communication module 98 may be a Bluetooth/Bluetooth Low Energy module.
  • other protocols may be used by the communication module 98, such as RFID, Zigbee, Wi-Fi, NFC, and others.
  • the controller 92 can be configured to cause the communication module 98 to transmit information to a remote computing device (e.g., a remote computer, tablet, smart phone, etc.), where that information regards the status of the device 64, such as reporting a delivery operation, performance characteristics of the motor 36, and so forth.
  • a drug delivery assembly 110 configured similarly to the delivery assembly discussed above can be mounted or disposed within an autoinjector drug delivery device 100 having an elongate housing 102.
  • the drug delivery assembly 110 includes a reservoir or cartridge 112 having a tubular housing 114 that is configured to store a drug 116 therein.
  • the reservoir 112 includes a delivery opening 118 at a distal end 120 thereof and an open proximal end 122.
  • a plunger 124 is disposed within the reservoir 112 adjacent to the proximal end 122 and engaged by a flexible plunger rod 126 having a coiled member 128. Similar to the above embodiment, movement of the plunger rod 126 is controlled by a drive mechanism 130 including a drive gear 132, a pinion gear 134, and a motor 136.
  • the autoinjector device 100 includes a spring housing 138 that, in this form, bends the flexible plunger rod 126 back upon itself to reduce a longitudinal length of the autoinjector device 100.
  • the spring housing 138 includes a curved bore or interior 140 extending therethrough.
  • the bore 140 includes a first end opening 142 adjacent to the reservoir 112 and a second, opposite end opening 144 oriented at an angle with respect to the first end opening 142.
  • the second end opening 144 can be oriented at about a 180 degree angle with respect to the first end opening 142 as shown in Fig. 11.
  • the autoinjector device 100 can include one or more assemblies or structures that insert or enable insertion of a cannula 146 into the patient P along an axis A along which the cannula 146 extends.
  • a first end 148 of the cannula 146 may be connected or connectable in fluid communication to the reservoir 112 and a second end 150 that may be inserted into the patient P.
  • the first end 148 of the cannula 146 may be disposed through a wall or septum 152 of the reservoir 112, and thus be connected in fluid communication with the reservoir 112.
  • the first end 148 of the cannula 146 may be disposed only partially through the wall 152 such that the cannula first end 148 may not be connected in fluid communication with the reservoir 112 until the second end 150 is inserted into the patient.
  • the wall 152 of this embodiment serves as a lock that maintains sterility of the reservoir 112.
  • the cannula first end 148 may again become disconnected from fluid communication with the reservoir 112.
  • the first end 148 may be described as connectable in fluid communication with the reservoir 112, although it will be recognized that there are other mechanisms by which the cannula first end 148 may be connectable, but not connected, in fluid communication with the reservoir 112.
  • the autoinjector device 100 can include a needle guard 154 to limit access to the cannula second end 150 when the autoinjector device 100 is not in use.
  • the needle guard 154 may have a biasing element (not shown) that urges the needle guard 154 away from the housing 102 and into a protracted position, as shown in Fig. 11 , such that a distal end 156 of the needle guard 154 extends beyond the cannula second end 150 until if and when the cannula 146 is inserted into a patient.
  • the injection of the cannula 146 may be actuated according to certain embodiments of the autoinjector device 100 by disposing the distal end 156 of the needle guard 154 on or against the skin of the patient P and applying a downward force.
  • the autoinjector device 100 may further include a controller 160 coupled to a communication module 162 for performing notification and communication actions similar to those described above with respect to the above embodiment and a user input device 164.
  • the controller 160 can include a processor 166 and a memory 168 storing logic that is executable by the processor 166.
  • the processor 166 may be programmed to carry out certain actions that the controller 160 is adapted to perform and the memory 168 may include one or more tangible non-transitory readable memories having logic (e.g., executable instructions) stored thereon, which instructions when executed by the processor 166 may cause the processor 166 to carry out the actions that the controller 160 is adapted to perform. Additionally, the controller 160 may include other circuitry for carrying out certain actions in accordance with the principles of the present disclosure.
  • the autoinjector device 100 in Fig. 11 has a storage state as shown and a delivery state (not shown) where the second end 150 of the cannula 146 extends beyond the distal end 156 of the needle guard 154.
  • the user can actuate the user input device 164 to cause the controller 160 to activate the motor 136 to rotate the pinion gear 134 and drive gear 132 to drive the flexible plunger rod 126 into the reservoir 112.
  • the plunger rod 126 engaged with the plunger 124, such as with a disc 150 configured as discussed above, drives the plunger 124 through the reservoir 112 to thereby expel the drug 116 into the cannula 146 and, subsequently, the patient P.
  • a disc 150 configured as discussed above
  • Numerous alternatives and configurations for the above embodiments are within the scope of this disclosure.
  • the devices 64, 100 can also utilize the flexible plunger rods 26, 126 in a straight configuration.
  • the spring of the plunger rod 26, 126 can have any desired diameter, such as 1/8 inch, 1/4 inch, 3/8 inch, 1/2 inch, and so forth.
  • the reservoir 112 can have a diameter sized to prevent buckling or can include an internal tubular portion having a diameter sized to prevent buckling.
  • the drive mechanism can utilize one or more springs, a source of pressurized gas or a source of a material that undergoes a phase change, such that the escaping gas or phase changing material that provides a motive force, or any other electromechanical system.
  • the motor 36, 136 can spin the plunger rod 26, 126.
  • the connection between the plunger rod 26, 126 and the plunger 24, 124 can include a bearing member.
  • the motor 36, 136 can be movable to follow the longitudinal movement of the plunger rod 26, 126 can the connection therebetween can include an expanding or telescoping member.
  • the above description describes various devices, assemblies, components, subsystems and methods for use related to a drug delivery device.
  • the devices, assemblies, components, subsystems, methods or drug delivery devices can further comprise or be used with a drug including but not limited to those drugs identified below as well as their generic and biosimilar counterparts.
  • the term drug as used herein, can be used interchangeably with other similar terms and can be used to refer to any type of medicament or therapeutic material including traditional and non-traditional pharmaceuticals, nutraceuticals, supplements, biologies, biologically active agents and compositions, large molecules, biosimilars, bioequivalents, therapeutic antibodies, polypeptides, proteins, small molecules and generics.
  • Non-therapeutic injectable materials are also encompassed.
  • the drug may be in liquid form, a lyophilized form, or in a reconstituted from lyophilized form.
  • the following example list of drugs should not be considered as all-inclusive or limiting.
  • the drug will be contained in a reservoir.
  • the reservoir is a primary container that is either filled or pre-filled for treatment with the drug.
  • the primary container can be a vial, a cartridge or a pre-filled syringe.
  • the reservoir of the drug delivery device may be filled with or the device can be used with colony stimulating factors, such as granulocyte colony-stimulating factor (G-CSF).
  • G-CSF agents include but are not limited to Neulasta® (pegfilgrastim, pegylated filgastrim, pegylated G-CSF, pegylated hu-Met-G-CSF) and Neupogen® (filgrastim, G-CSF, hu-MetG-CSF).
  • the drug delivery device may contain or be used with an erythropoiesis stimulating agent (ESA), which may be in liquid or lyophilized form.
  • ESA erythropoiesis stimulating agent
  • An ESA is any molecule that stimulates erythropoiesis.
  • an ESA is an erythropoiesis stimulating protein.
  • erythropoiesis stimulating protein means any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, by binding to and causing dimerization of the receptor.
  • Erythropoiesis stimulating proteins include erythropoietin and variants, analogs, or derivatives thereof that bind to and activate erythropoietin receptor; antibodies that bind to erythropoietin receptor and activate the receptor; or peptides that bind to and activate erythropoietin receptor.
  • Erythropoiesis stimulating proteins include, but are not limited to, Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methyoxy polyethylene glycol-epoetin beta), Flematide®, MRK- 2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), Binocrit® (epoetin alfa), epoetin alfa Hexal, Abseamed® (epoetin alfa), Ratioepo® (epoetin theta), Eporatio® (epoetin theta), Biopoin® (epoetin theta), epoetin alfa,
  • proteins are the specific proteins set forth below, including fusions, fragments, analogs, variants or derivatives thereof: OPGL specific antibodies, peptibodies, related proteins, and the like (also referred to as RANKL specific antibodies, peptibodies and the like), including fully humanized and human OPGL specific antibodies, particularly fully humanized monoclonal antibodies; Myostatin binding proteins, peptibodies, related proteins, and the like, including myostatin specific peptibodies; IL-4 receptor specific antibodies, peptibodies, related proteins, and the like, particularly those that inhibit activities mediated by binding of IL-4 and/or IL-13 to the receptor; Interleukin 1-receptor 1 ("IL1-R1 ") specific antibodies, peptibodies, related proteins, and the like; Ang2 specific antibodies, peptibodies, related proteins, and the like; NGF specific antibodies, peptibodies, related proteins, and the like; CD
  • IL1-R1 Interleuk
  • adalimumab Vectibix® (panitumumab), Xgeva® (denosumab), Prolia® (denosumab), Enbrel® (etanercept, TNF-receptor /Fc fusion protein, TNF blocker), Nplate® (romiplostim), rilotumumab, ganitumab, conatumumab, brodalumab, insulin in solution; Infergen® (interferon alfacon-1); Natrecor® (nesiritide; recombinant human B-type natriuretic peptide (hBNP); Kineret® (anakinra); Leukine® (sargamostim, rhuGM-CSF); LymphoCide® (epratuzumab, anti-CD22 mAb); BenlystaTM (lymphostat B, belimumab, anti-BlyS mAb); Metalyse® (
  • Reopro® (abciximab, anti-GP llb/llia receptor monoclonal antibody); Actemra® (anti- IL6 Receptor mAb); Avastin® (bevacizumab), HuMax-CD4 (zanolimumab); Rituxan® (rituximab, anti-CD20 mAb); Tarceva® (erlotinib); Roferon-A®-(interferon alfa-2a); Simulect® (basiliximab); Prexige® (lumiracoxib); Synagis® (palivizumab); 146B7- CHO (anti-IL15 antibody, see U.S. Patent No.
  • Tysabri® natalizumab, anti-?4integrin mAb
  • Valortim® MDX-1303, anti-B. anthracis protective antigen mAb
  • ABthraxTM ABthraxTM
  • Xolair® omalizumab
  • ETI211 anti-MRSA mAb
  • IL-1 trap the Fc portion of human lgG1 and the extracellular domains of both IL-1 receptor components (the Type I receptor and receptor accessory protein)
  • VEGF trap Ig domains of VEGFR1 fused to lgG1 Fc
  • Zenapax® diaclizumab
  • Zenapax® daclizumab, anti-IL-2R?
  • mAb mAb
  • Zevalin® ibritumomab tiuxetan
  • Zetia® ezetimibe
  • Orencia® atacicept, TACI-lg
  • anti-CD80 monoclonal antibody galiximab
  • anti-CD23 mAb lumiliximab
  • BR2-Fc huBR3 / huFc fusion protein, soluble BAFF antagonist
  • ONTO 148 golimumab, anti-TNF?
  • HGS-ETR1 mapatumumab; human anti-TRAIL Receptor-1 mAb
  • HuMax-CD20 ovallizumab, anti-CD20 human mAb
  • HuMax-EGFR zalutumumab
  • MDX-010 ipilimumab, anti- CTLA-4 mAb and VEGFR-1 (IMC-18F1)
  • anti-BR3 mAb anti-C.
  • mAb (MEDI-545, MDX-1103); anti-IGF1 R mAb; anti-IGF-1 R mAb (HuMax-lnflam); anti-IL12 mAb (ABT-874); anti-IL12/IL23 mAb (CNTO 1275); anti-IL13 mAb (CAT-354); anti- IL2Ra mAb (HuMax-TAC); anti-IL5 Receptor mAb; anti-integrin receptors mAb (MDX-018, CNTO 95); anti-IP10 Ulcerative Colitis mAb (MDX-1100); BMS-66513; anti-Mannose Receptor/hCG?
  • mAb (MDX-1307); anti-mesothelin dsFv-PE38 conjugate (CAT- 5001); anti-PD1 mAb (MDX-1106 (ONO-4538)); anti-PDGFR? antibody (IMC-3G3); anti-TGFB mAb (GC-1008); anti-TRAIL Receptor-2 human mAb (HGS-ETR2); anti-TWEAK mAb; anti-VEGFR/Flt-1 mAb; and anti-ZP3 mAb (HuMax-ZP3).
  • the drug delivery device may contain or be used with a sclerostin antibody, such as but not limited to romosozumab, blosozumab, or BPS 804 (Novartis) and in other embodiments, a monoclonal antibody (IgG) that binds human Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9).
  • a sclerostin antibody such as but not limited to romosozumab, blosozumab, or BPS 804 (Novartis) and in other embodiments, a monoclonal antibody (IgG) that binds human Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9).
  • PCSK9 specific antibodies include, but are not limited to, Repatha® (evolocumab) and Praluent® (alirocumab).
  • the drug delivery device may contain or be used with rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant or panitumumab.
  • the reservoir of the drug delivery device may be filled with or the device can be used with IMLYGIC® (talimogene laherparepvec) or another oncolytic HSV for the treatment of melanoma or other cancers including but are not limited to OncoVEXGALV/CD; OrienXOIO; G207, 1716; NV1020; NV12023; NV1034; and NV1042.
  • the drug delivery device may contain or be used with endogenous tissue inhibitors of metalloproteinases (TIMPs) such as but not limited to TIMP-3.
  • TIMPs tissue inhibitors of metalloproteinases
  • Antagonistic antibodies for human calcitonin gene-related peptide (CGRP) receptor such as but not limited to erenumab and bispecific antibody molecules that target the CGRP receptor and other headache targets may also be delivered with a drug delivery device of the present disclosure.
  • CGRP human calcitonin gene-related peptide
  • bispecific antibody molecules that target the CGRP receptor and other headache targets may also be delivered with a drug delivery device of the present disclosure.
  • bispecific T cell engager (BiTE®) antibodies such as but not limited to BLINCYTO® (blinatumomab) can be used in or with the drug delivery device of the present disclosure.
  • the drug delivery device may contain or be used with an APJ large molecule agonist such as but not limited to apelin or analogues thereof.
  • a therapeutically effective amount of an anti-thymic stromal lymphopoietin (TSLP) or TSLP receptor antibody is used in or with the drug delivery device of the present disclosure.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Dermatology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne une tige de piston flexible, un mécanisme d'administration de médicament, un dispositif d'administration de médicament et des procédés qui utilisent la tige de piston flexible pour effectuer des opérations d'administration de médicament. Dans des modes de réalisation, la tige de piston flexible peut être stockée dans une configuration incurvée pour ainsi réduire une empreinte du mécanisme et du dispositif d'administration de médicament.
EP19703535.5A 2018-01-17 2019-01-17 Mécanisme d'administration de médicament Pending EP3740264A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201862618288P 2018-01-17 2018-01-17
PCT/US2019/013905 WO2019143753A1 (fr) 2018-01-17 2019-01-17 Mécanisme d'administration de médicament

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EP3740264A1 true EP3740264A1 (fr) 2020-11-25

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US (1) US11766519B2 (fr)
EP (1) EP3740264A1 (fr)
IL (1) IL275633A (fr)
MA (1) MA51617A (fr)
WO (1) WO2019143753A1 (fr)

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US11497847B1 (en) 2021-02-19 2022-11-15 Fresenius Kabi Deutschland Gmbh Wearable injector with adhesive substrate
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US11419976B1 (en) 2021-04-30 2022-08-23 Fresenius Kabi Deutschland Gmbh Wearable drug delivery device with pressurized fluid dispensing
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US11529459B1 (en) 2021-04-30 2022-12-20 Fresenius Kabi Deutschland Gmbh Wearable injector with adhesive module
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Publication number Publication date
IL275633A (en) 2020-08-31
US20210060259A1 (en) 2021-03-04
WO2019143753A1 (fr) 2019-07-25
MA51617A (fr) 2020-11-25
US11766519B2 (en) 2023-09-26

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